Sr Associate Regulatory Affairs

Amgen is a leading human therapeutics company in the biotechnology industry. For more than 35 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients. Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness.

Amgen is searching for a Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) Senior Associate . RA CMC facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

The RA CMC team generates the regulatory CMC strategy of the product/variation and provides feedback to the technical teams, including plans for execution of the strategy. The RA CMC Senior Associate will interface with the Amgen RA CMC leads, product teams, regional offices, and site teams for specific strategies or activities that impact a product.

The RA CMC Senior Associate will be responsible for varying levels of product support, including leading projects, based upon their experience level.

Additional job responsibilities of the RA CMC Senior Associate include:

• Contribute to the organization and preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products to meet the strategy defined by the global CMC team.

• Document CMC submissions and related communications in InSight Manager for Registrations (IMR); archiving documents in document management systems.

• Initiate and maintain CMC product timelines at the direction of product lead.

• Process regulatory assessments of change control requests.

• Train staff on select CMC procedures and systems.

• Interface with regulatory operations staff.

• Contribute to CMC product teams: interacts with authors/reviewers with respect to delivery of

documents required for regulatory submissions.

• Provide report status of activities and projects to teams and department.

• Participate in cross-functional special project teams.

• Contributes to the design and content development of department training programs.

Basic Qualifications:

Master's degree

OR

Bachelor's degree and 2 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

Associate's degree and 6 years of Pharmaceutical/Biotech and/or Healthcare and/or Med Device and/or

Scientific experience

OR

High school diploma / GED and 8 years of Pharmaceutical/Biotech and/or Healthcare and/or Med

Device and/or Scientific experience

Preferred Qualifications:

• BS degree in Life Science

• Experience in manufacture, testing (QC/QA or clinical), or distribution in Pharmaceutical/Biotech

industry

• Regulatory CMC experience

• Process Development experience

• Quality Assurance, or Analytical development experience

• CMC-specific regulatory knowledge & experience

• Strong & effective oral and written communication skills; proven
Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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